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发表于 2003-5-24 19:44
[B]Rescue Treatment with Hepsera (adefovir dipivoxil) for Epivir-HBV (lamivudine)-resistant Patients Pre- and Post- Liver Transplantation[/B]
Candidates for liver transplantation who develop Epivir-HBV (lamivudine)-resistant strains of HBV are at increased risk of hepatic decompensation and recurrence of hepatitis B after liver transplantation.
The aim of this study was to assess the efficacy and safety of Hepsera (adefovir dipivoxil 10 mg) once daily to treat patients with lamivudine-resistant hepatitis B (HBV).
4 patients (12 men, 51 years old, 4 HBeAg positive) with lamivudine-resistant HBV, i.e. elevated ALT, HBV-DNA >10(6) copies/mL by HBV Roche Amplicor Monitor, YMDD mutants, either waiting for liver transplantation (n=10) or with hepatitis B recurrence post-transplantation (n=4), were treated with adefovir 10 mg once daily (Gilead Sciences) for 2-21 months (median 6 months) added to ongoing lamivudine treatment.
HBV-DNA levels decreased from a median of 2x10(7) copies/ml (range10(6)-10(9) at enrolment to 3x10(5), 5x10(4), 4x10(4), and 2x10(4) copies/ml at month 1, 2, 3 and 6 of treatment, respectively.
By month 3, 9 patients had at least a 3 log reduction of serum HBV-DNA, 4 patients had a 2 log decrease and 1 patient had a 1 log decrease. By month 6, HBV-DNA became undetectable by PCR (<200 copies/ml) in 5 of 6 patients with pre-treatment HBV-DNA <10(8) copies/ml compared to 0 of the 4 with >10(8) copies/ml.
In 2 of 3 patients with HBV-DNA levels between 10(5)-10(6) copies/ml at month 6, continuous treatment with ADV up to month 12 did not significantly decrease viremia further. ALT levels progressively decreased during treatment: 7 (50%) patients had normal ALT by month 3 and 10 (74%) by month 6. Child-Pugh score improved by at least 2 points in 6 of 8 Child-Pugh B/C patients.
Liver transplantation was performed in 2 patients with HCC and pre-OLT HBV-DNA levels of 4x10(2) and 4x10(4) copies/ml, respectively: none had HBV recurrence after 12 months of follow-up (both were treated also with HBIg).
None of the patients had adefovir-related side effects or significant changes of renal function.
Conclusions: Treatment with adefovir dipivoxil resulted in a rapid and significant reduction of HBV DNA in patients with lamivudine resistant HBV. In a minority of patients viremia remained detectable at levels of 10(5)-10(6) copies/ml despite >12 months of treatment.
05/23/03
Reference
P Lampertico and others. Rescue Treatment with Adefovir Dipivoxil for Lamivudine Resistant Patients pre- and post- Liver Transplantation. Abstract 341 (topic forum). Abstracts of Digestive Disease Week 2003. May 17-22, 2003. Orlando, FL, USA.
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